Abstract Despite growing interest in psychedelic-assisted psychotherapy, research investigating the psychotherapeutic components is lacking. This leaves unanswered questions regarding the psychotherapy's necessity and form. This observational study addresses this gap by measuring the outcomes of a psilocybin truffle retreat, followed by the outcomes of two p...
This phase II trial tests the safety, side effects and how well group retreat psilocybin therapy works for the treatment of anxiety and depression in patients with solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic) or with hematologic cancers for which no treatment is currently available (incur...
INTRODUCTION: Psilocybin shows promise for treatment-resistant depression (TRD), but long-term data are limited. This study examined the antidepressant effect of one or two psilocybin doses with adjunct psychotherapy in TRD until twelve months. METHODS: This is a naturalistic follow-up of a phase 2b, randomized, active placebo-controlled trial, where partici...
In this single-arm Phase 2 study, the researchers are assessing the feasibility of the group retreat format for clinicians and explores different 'doses' of preparation. A sequential dose-escalation design is used. The study will recruit healthcare clinicians (physicians, nurses, nurse practitioners, physician assistants) aged 25-70 years currently in clinic...
Introduction: Psilocybin therapy has demonstrated efficacy for cancer-related anxiety and depression, but resource-intensive individual treatment models raise important questions for psychedelic public health about equitable access and scalability. In our prior Phase 1/2 study of group retreat psilocybin therapy for patients with metastatic cancer, we observ...
Background: Psilocybin is a promising therapy for cancer-related distress, but existing individual treatment models are resource intensive. In this study, we designed and tested a group model of psilocybin therapy for people with metastatic cancer and cancer-related anxiety and depression. Method: Eligibility criteria included metastatic cancer, moderate-to-...
Background: Psilocybin therapy is an emerging treatment for cancer-related anxiety, depression, and existential distress. Most clinical trials to date have studied individual models of psilocybin therapy, but group models may offer increased access and benefits of community. Purpose: This technical report describes a group facilitation model developed for an...
Abstract Substance use disorders (SUDs) are increasingly common in the United States, and while this may be a dilemma for those using, it also inflicts problems for those around the user. In couples where drug abuse is present, negative codependent characteristics can arise independently in the non-user, having a damaging effect on the couple dynamic. This i...
Adolescent depression is a significant public health concern, yet treatment options remain limited, particularly due to age- and sex-related differences in antidepressant efficacy. This study explored for the first time the potential antidepressant-like response of psilocybin in adolescence by examining acute, repeated and persistent effects in Sprague-Dawle...
This phase I trial tests the safety and side effects of a second episode of psilocybin-assisted group therapy and how well it works in treating anxiety and distress in patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and had a partial response to their first retreat. Up to 50% of patient...
Supplement 1. Additional tables presenting primary and secondary outcomes, sensitivity analyses, and exploratory findings. Table A1. ITT analyses for QIDS-SR-16 and MBI-HSS-MP. Table A2. Adjusted ITT analyses for QIDS-SR-16 and MBI-HSS-MP. Table B1. Intent-To-Treat (ITT) Analysis for Demoralization Scale (DSII) and PTSD Checklist for DSM-5 (PCL-5). Table B2....
= 7) in an open-label trial investigating PAT for cancer-related demoralization and chronic pain. Patients and caregivers were interviewed after their last treatment session in the trial; facilitators were interviewed at the end of the entire trial. Rapid qualitative analysis identified specific domains for improvement in the treatment protocol based on the ...
OBJECTIVE: Unipolar and bipolar depression severely impact millions of individuals worldwide, with a significant subset of cases remaining unresponsive to conventional treatments. Psilocybin-assisted psychotherapy (PAP) has demonstrated therapeutic efficacy; however, the optimal psychotherapeutic approach remains undefined, ranging from unstructured models r...
For a new clinical trial testing a group retreat-based format of psilocybin-assisted therapy, our research team created an initial set of practice guidelines that aimed to describe facilitator use of touch in a way that is ethical, supportive, and minimizes harm. In our first three retreats, however, we had two unexpected experiences with touch that led us t...
Introduction: Psilocybin, a tryptamine psychedelic, has been touted in the media both historically and recently as a potential game-changing mental health therapeutic. ClinicalTrials.gov has over one hundred and thirty psilocybin clinical trials listed covering the last twenty years. The single most important aspect of any therapeutic is to gain approval for...
The purpose of the study is to understand the feasibility of a resilience focused community of practice program that includes psilocybin-assisted therapy for End-of-Life Distress. The community of practice refers to a research informed group therapy process that runs over a 10-week period of time and includes one group administered psilocybin-assisted therap...
Preparing participants for psychedelic experiences is crucial for ensuring these experiences are safe, and potentially, beneficial. However, there is currently no validated measure to assess the extent to which participants are well-prepared for such experiences. Our study aimed to address this gap by developing, validating, and testing the Psychedelic Prepa...
The psychedelic 5-HT2A receptor (5HT2AR) agonist psilocybin (or the active metabolite psilocin) has emerged as potential useful drug for various neuropsychiatric diseases, with a rapid onset of therapeutic activity. However, the mechanisms responsible for such effects remain incompletely characterized. We aimed to study in vitro pharmacological profile and i...
